Ketogenic diet for patients with high-grade gliomas and brain metastases
A "Classic" Ketogenic Diet as a Complementary Therapeutic Management on Patients With High-grade Gliomas and Brain Metastases.
This study is testing if a special high-fat, low-carb diet can help people with aggressive brain tumors live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Attikon Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Chaïdári, Athens and 1 other locations) |
| Trial ID | NCT05564949 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a classic ketogenic diet (CKD) on patients diagnosed with high-grade gliomas and brain metastases. The CKD is designed to reduce glucose intake and promote ketosis, potentially extending survival for these patients. Participants will receive a tailored diet plan developed by dieticians to meet their energy needs while achieving ketosis. The primary outcome is to assess the efficacy of this dietary intervention compared to historical controls. The study aims to provide insights into the therapeutic potential of dietary changes in managing aggressive brain tumors.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with newly diagnosed, histologically confirmed glioblastoma grade 4 or secondary metastases who can adhere to the ketogenic diet.
Not a fit: Patients with diabetes mellitus or those with a life expectancy greater than three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly extend the survival of patients with high-grade gliomas and brain metastases.
How similar studies have performed: While evidence for the ketogenic diet in clinical practice is limited, recent findings suggest potential therapeutic effects, indicating that this approach is novel and may offer new insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 * Karnofsky Performance Score of 50 or more. * Newly diagnosed, histologically confirmed glioblastoma grade 4, or secondary metastases or progression after surgical resection, radiation and chemotherapy. * Normal function of liver and kidneys * Ability to sign informed consent form Exclusion Criteria: * Diabetes mellitus * Life expectancy \>3 months * Inability to adhere to diet * Inability to give informed consent form * Cholecystectomy last 1 year (before the study entry) * Diagnosis of genetic disorder of fat metabolism
Where this trial is running
Chaïdári, Athens and 1 other locations
- Arezina Kasti — Chaïdári, Athens, Greece (Recruiting)
- Attikon University General Hospital — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Arezina N. Kasti, RD
- Email: kastiare@yahoo.gr
- Phone: +306942917860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.